Field Safety Notice for electrophysiology system Carto 3, Biosense Webster
2009.12.21
Product group Medical electronics / Electromedical devices
Reference 04477/09
Biosense Webster has issued a Field Safety Notice concerning the electrophysiology (EP) system Carto 3. During operation of a Bloom EP Stimulator device in conjunction with radiofrequency (RF) generators and other EP equipment, including the Carto 3 a potential hazard exists of formation of micro-bubbles in the blood within the heart chamber. Recommendations when connecting an EP Stimulator to Carto 3 system shall avoid possible patient injury.